China NMPA Product Recall - Monitor defibrillator

Philips Medical Systems, through its agent Philips (China) Investment Co., Ltd., initiated a voluntary Level 2 recall for specific monitored defibrillators, a development formally documented by the National Medical Products Administration (NMPA) in November 2017. The primary issue concerns the failure to obtain accurate End-tidal CO2 (EtCO2) measurement values when operating the EtCO2 monitoring function on models M3535A and M3536A. This defect can prevent medical professionals from identifying crucial intubation or ventilation problems, impede the monitoring of CO2 and respiratory rates, and force reliance on less precise parameters for ventilation adjustments, potentially exposing patients to dangerous situations. Operating under the NMPA's medical device recall framework, Philips submitted the necessary report. Importantly, the affected product batches were not sold in China; therefore, the required corrective actions within the Chinese market were deemed "Not applicable," as no units were distributed domestically. The recall primarily targeted other regions, such as Canada.